U.S. is 'flying blind' with bird flu, repeating mistakes of COVID, health experts say

During COVID, shortages of tests led to backlogs in getting tested. Experts worry that the U.S. hasn't learned from those mistakes and wouldn't be prepared for a major bird flu outbreak.

But Nuzzo and other researchers are concerned because the CDC and public health labs aren’t generally where doctors order tests from. That job tends to be done by major clinical laboratories run by companies and universities, which lack authorization for bird flu testing.infected in 12 states as of June 18 — researchers said the CDC and FDA are not moving fast enough to remove barriers that block clinical labs from testing.

Although the three farmworkers diagnosed with the disease this year in the United States had only mild symptoms, like a runny nose and inflamed eyes, others may not be so lucky. The flu treatment Tamiflu works only when given soon after symptoms start. “I really worry about a testing scheme in which busy clinicians need to figure this out,” Nuzzo said.The other reason to involve clinical laboratories is so the nation can ramp up testing if the bird flu is suddenly detected among people who didn’t catch it from cattle.

But Saladi grew increasingly anxious about the ability to reference the CDC’s data in the company’s FDA application. “Do you have an update with respect to the right of reference?” he asked the CDC on May 13. “If there are any potential sticking points with respect to this, would you mind letting us know please?”

The CDC has given seven companies, including Neelyx, licenses for its tests — although none have been cleared to use them by the FDA. Only one of those companies asked for the right of reference, Shah said. The labs may be assisted by additional material that the agency is developing now, to allow them to complete the analyses — even without the reference.

Source: Healthcare Press (healthcarepress.net)

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